Paper No. ____
`Filed: October 2, 2015
`
`Filed on behalf of: Zimmer Biomet Holdings, Inc.
`
`By: Naveen Modi (Zimmer-FMB-IPR@paulhastings.com)
`
`Srikala P. Atluri (Zimmer-FMB-IPR@paulhastings.com)
`
`Paromita Chatterjee (Zimmer-FMB-IPR@paulhastings.com)
`
`Paul Hastings LLP
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`ZIMMER BIOMET HOLDINGS, INC.
`Petitioner
`
`v.
`
`FOUR MILE BAY, LLC
`Patent Owner
`
`
`
`
`U.S. Patent No. 8,506,642
`
`
`
`
`
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 8,506,642
`
`
`
`
`
`
`
`
`
`
`
`

`
`TABLE OF CONTENTS
`
`V. 
`
`Page
`I. 
`INTRODUCTION .......................................................................................... 1 
`II.  MANDATORY NOTICES UNDER 37 C.F.R. § 42.8 .................................. 2 
`III. 
`PAYMENT OF FEES UNDER 37 C.F.R. §§ 42.15 AND 42.103 ................ 2 
`IV.  GROUNDS FOR STANDING AND IDENTIFICATION OF
`CHALLENGE ................................................................................................ 3 
`BACKGROUND ............................................................................................ 3 
`A. 
`The ’642 Patent .................................................................................... 4 
`B. 
`Prosecution History of the ’642 Patent and Its Parent
`Application ........................................................................................... 8 
`1. 
`Prosecution of the Parent Application ....................................... 8 
`2. 
`The ’642 Patent Prosecution .................................................... 10 
`VI.  CLAIM CONSTRUCTION ......................................................................... 12 
`A. 
`“Completely Porous Metal Structure” (Claims 1-3) .......................... 14 
`B. 
`“[A] Porous Structure . . . That Emulate[s] a Size and a Shape
`of a Porous Structure of Natural Human Bone” (Claim 1) / “[A]
`Porous Structure . . . [That] Emulates a Porous Structure of
`Natural Human Bone” (Claim 2 and 3) .............................................. 15 
`VII.  CLAIMS 1-4 OF THE ’642 PATENT ARE UNPATENTABLE ............... 17 
`A. 
`The Board Should Adopt Both of the Proposed Grounds .................. 17 
`Ground 1: Claims 1-4 Are Obvious Over Zolman in View of
`B. 
`Rostoker .............................................................................................. 18 
`Overview of the Combination of Zolman and Rostoker .......... 18 
`1. 
`2. 
`Claim 1 ..................................................................................... 23 
`3. 
`Claim 2 ..................................................................................... 34 
`4. 
`Claim 3 ..................................................................................... 39 
`5. 
`Claim 4 ..................................................................................... 44 
`Ground 2: Claims 1-4 Are Obvious Over Zolman in View of
`Bobyn .................................................................................................. 44 
`Overview of the Combination of Zolman and Bobyn .............. 45 
`1. 
`2. 
`Claim 1 ..................................................................................... 49 
`3. 
`Claim 2 ..................................................................................... 54 
`
`C. 
`
`i
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`

`
`TABLE OF CONTENTS
`(continued)
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`Page
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`
`
`Claim 3 ..................................................................................... 57 
`4. 
`Claim 4 ..................................................................................... 60 
`5. 
`VIII.  CONCLUSION ............................................................................................. 60 
`
`
`ii
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`

`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Federal Cases
`
`In re Cuozzo Speed Techs., LLC,
`793 F.3d 1268 (Fed. Cir. 2015) .......................................................................... 12
`
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) .....................................................................................passim
`
`In re Translogic Tech., Inc.,
`504 F.3d 1249 (Fed. Cir. 2007) .......................................................................... 13
`
`In re Yamamoto,
`740 F.2d 1569 (Fed. Cir. 1984) .......................................................................... 13
`
`Statutes
`
`35 U.S.C.
`§ 102(b) ................................................................................................................. 3
`§ 103(a) ............................................................................................................. 2, 3
`
`Other Authorities
`
`37 C.F.R.
`§ 42.1(b) .............................................................................................................. 18
`§ 42.8 ..................................................................................................................... 2
`§ 42.15 ................................................................................................................... 2
`§ 42.103 ................................................................................................................. 2
`
`77 Fed. Reg. 48,756 (Aug. 14, 2012) ...................................................................... 13
`
`
`
`iii
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`

`
`LIST OF EXHIBITS
`
`”°°
`
`1001
`
`U.S. Patent No- 8,506,642 to Lyren
`
`1002
`
`Declaration of Dr. Timothy P. Harrigan
`
`1003
`
`Prosecution History of U.S. Application No. 10/446,069
`
`1004
`
`Prosecution History of U S Application No 11/409 611
`
`1005
`
`U.S. Patent No. 5,018,285 to Zolman et al. (“ZoIman”)
`
`1006
`
`1007
`
`J.D. Bobyn et al. “Characteristics of Bone Ingrowth and Interface
`Mechanics of a New Porous Tantalum Biomaterial,” J. of Bone and Joint
`
`Surgery, Vol. 81—B, No- 5, pp. 907-14 (Sept. 1999).
`
`1008
`
`Expert from Webster’s Third New International Dictionary (2002)
`
`1009
`
`M. Martens et al. “The Mechanical Characteristics of Cancellous Bone at
`
`the Upper Femoral Region,” J. Biomechanics, Vol. 16, No. 12, pp. 971-
`83 (1983).
`
`U.S. Patent No. 3,906,550 to Rostoker et al. (“Rostoker”)
`
`1010
`
`Reserved
`
`101 1
`
`Reserved
`
`1012
`
`Reserved
`
`1013
`
`D. Carter et al. “The compressive Behavior of Bone as a Two-Phase
`Porous Structure,” J. of Bone and Joint Surgery, Vol. 59—A, No. 7, pp.
`954-962 (Oct. 1977)
`
`iv
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,506,642
`
`I.
`
`INTRODUCTION
`Zimmer Biomet Holdings, Inc. (“Petitioner”) requests inter partes review of
`
`claims 1-4 of U.S. Patent No. 8,506,642 (“the ’642 patent”) (Ex. 1001), which is
`
`assigned to Four Mile Bay, LLC (“Patent Owner”). The ’642 patent broadly
`
`claims known features of hip implants including a “neck body” and a “bone
`
`fixation body” that is formed as a “completely porous metal structure.” Ex. 1001
`
`at 6:24-8:27. While the claims recite that the porous structure of the bone fixation
`
`body “emulate[s] a size and a shape of a porous structure of natural human bone”
`
`(claim 1) and “emulates a porous structure of natural human bone” (claims 2 and
`
`3), these features were well-known at the time of the alleged invention. Indeed,
`
`during prosecution, the Examiner rejected Applicant’s contentions that these
`
`features were patentable over the prior art. See infra Section V.B. Applicant
`
`ultimately obtained the ’642 patent by contending that a hip implant having an
`
`interface with a trapezoidal cross-sectional shape was a meaningful distinction
`
`over the prior art. See id. However, as discussed in more detail below, hip
`
`implants including a bone fixation body having a porous structure and a
`
`trapezoidal cross-sectional shape were well-known long before the earliest filing
`
`date of the ’642 patent.
`
`This petition shows that there is a reasonable likelihood that Petitioner will
`
`prevail with respect to at least one of the challenged claims, and thus a trial should
`
`1
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,506,642
`
`be instituted. This petition also establishes by a preponderance of the evidence that
`
`claims 1-4 of the ’642 patent are unpatentable under 35 U.S.C. § 103(a).
`
`Accordingly, a trial should be instituted and these claims should be canceled.
`
`II. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8
`Real Party-in-Interest: Pursuant to 37 C.F.R. § 42.8(b)(1), Petitioner
`
`identifies Zimmer Biomet Holdings, Inc., as the real party-in-interest.
`
`Related Matters: Pursuant to 37 C.F.R. § 42.8(b)(2), Petitioner identifies the
`
`following related matter. The ’642 patent and a continuation-in-part of the ’642
`
`patent, U.S. Patent No. 8,821,582 (“the ’582 patent”), are involved in Four Mile
`
`Bay LLC v. Zimmer Holdings, Inc., No. 3:15-cv-00063 (N.D. Ind.) (PPS)-(CAN).
`
`Petitioner is concurrently filing a petition for inter partes review of the ’582 patent
`
`challenging claims 1-5, 7-11, 13-15, and 17-20.
`
`Counsel and Service Information: Lead counsel is Naveen Modi (Reg. No.
`
`46,224). Srikala P. Atluri (pro hac vice admission to be requested) and Paromita
`
`Chatterjee (Reg. No. 63,721) are back-up counsel. The mailing address for all
`
`correspondence is Paul Hastings LLP, 875 15th St. N.W., Washington, D.C.,
`
`20005 (Telephone: 202.551.1700/Fax: 202.551.1705). Petitioner consents to
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`electronic service of documents at Zimmer-FMB-IPR@paulhastings.com
`
`III. PAYMENT OF FEES UNDER 37 C.F.R. §§ 42.15 AND 42.103
`
`2
`
`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,506,642
`
`Petitioner submits the required fees with this petition. Please charge any
`
`additional fees required for this proceeding to Deposit Account No. 50-2613.
`
`IV. GROUNDS FOR STANDING AND IDENTIFICATION OF
`CHALLENGE
`
`Claims 1-4 of the ’642 patent are unpatentable in view of the following prior
`
`art references: U.S. Patent No. 5,018,285 to Zolman et al. (“Zolman”) (Ex. 1005);
`
`U.S. Patent No. 3,906,550 to Rostoker et al. (“Rostoker”) (Ex. 1006); J.D. Bobyn
`
`et al., “Characteristics of Bone Ingrowth and Interface Mechanics of a New Porous
`
`Tantalum Biomaterial,” J. of Bone and Joint Surgery, Vol. 81-B, No. 5 (Sept.
`
`1999) (“Bobyn”) (Ex. 1007). Zolman issued on May 28, 1991, Rostoker issued on
`
`September 23, 1975, and Bobyn was published in September 1999. These
`
`references are all prior art under 35 U.S.C. § 102(b).
`
`Claims 1-4 of the ’642 patent should be cancelled in view of the following
`
`grounds: Claims 1-4 are unpatentable under 35 U.S.C. § 103(a) as obvious over
`
`Zolman in view of Rostoker; and claims 1-4 are unpatentable under 35 U.S.C.
`
`§ 103(a) as obvious over Zolman in view of Bobyn. Petitioner certifies that the
`
`’642 patent is available for inter partes review, and that Petitioner is not barred or
`
`estopped from requesting such review of the ’642 patent on the grounds identified.
`
`V. BACKGROUND
`The ’642 patent issued from U.S. Patent Application No. 11/409,611 (“the
`
`’642 patent application”), filed April 24, 2006, and purports to be a continuation of
`
`3
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`Petition for Inter Partes Review of U.S. Patent No. 8,506,642
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`U.S. Patent Application No. 10/446,069 (“the ’069 application” or “parent
`
`application”), filed May 27, 2003, now abandoned. Ex. 1001 at title page.
`
`A. The ’642 Patent
`The ’642 patent relates to hip implants, as shown in the embodiments of
`
`Figures 1 and 2 below. See e.g., Ex. 1001 at Title, Abstract, 1:9-11, 2:65-66. The
`
`disclosed hip implant 10 includes two components or bodies: a neck body 14 and a
`
`bone fixation body 16. See e.g., id. at Abstract, 3:2-4, Figs. 1-2. Figure 2 shows
`
`hip implant 10 embedded in an intramedullary canal 52 of a femur 50 of a patient:
`
`Id. at 3:37-39. See also Ex. 1002 at ¶ 12.
`
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`4
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`Petition for Inter Partes Review of U.S. Patent No. 8,506,642
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`
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`Neck body 14 can be formed from a solid metal piece of titanium, titanium
`
`alloy, or other metals or alloys. Ex. 1001 at 3:20-22. As shown above, a collar 22
`
`of neck body 14 is configured to seat against a resected end 56 of the femur about
`
`an entrance 57 to intramedullary canal 52. Id. at 3:11-12, 3:41-43. Neck body 14
`
`extends outwardly from the resected end of the intramedullary canal 52 and
`
`includes a base portion 20 with a neck portion 24 that is configured to connect hip
`
`implant 10 to a femoral ball 19 which is received by an acetabular component (not
`
`shown). Id. at 3:5-8, 3:14-15, 3:22-25, 3:41-46. A distal end surface 21 of neck
`
`body 14 connects or fuses to a proximal end surface 40 of bone fixation body 16 at
`
`a junction 44. Id. at 3:28-30. See also Ex. 1002 at ¶ 13.
`
`
`
`The specification includes an embodiment (shown in
`
`Figure 5) in which a protrusion 74 extends from the distal end
`
`surface of the neck body into the bone fixation body. Ex. 1001
`
`at 5:16-18. Protrusion 74 can have any shape, for example,
`
`“cylindrical or polygonal, such as rectangular or square.” See
`
`id. at 5:35-36. Protrusion 74 can partially extend into the bone
`
`fixation body or protrusion 74 can extend farther toward the
`
`distal end surface 82 of the bone fixation body. Id. at 5:26-30.
`
`In the latter embodiment, “[t]he protrusion gradually tapers as it
`
`extends toward the distal end surface.” Id. at 5:30-31. According to the ’642
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`5
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`Petition for Inter Partes Review of U.S. Patent No. 8,506,642
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`patent, “the protrusion can be sized and shaped to provide a strong connection
`
`between the neck body and bone fixation body” and “provide an anti-rotational
`
`interface between the neck body and bone fixation body.” Id. at 5:40-44. See also
`
`Ex. 1002 at ¶ 14, 15.
`
`
`
`As shown in the figures above, bone fixation body 16 has an elongated
`
`tapering shape that extends from proximal end surface 40 or 80 to a rounded distal
`
`end surface 42 or 82. Ex. 1001 at 3:26-28, 5:21-23, Figs. 1, 6. The elongated
`
`tapering shape of bone fixation body 16 also has “a slight bow.” Id. at 4:49-50,
`
`Figs. 1-5. The specification states that “[t]he bone fixation body . . . may have
`
`other configurations and still be within the scope of the invention.” Id. at 5:50-52.
`
`In certain embodiments, the specification describes the bone fixation body as
`
`having “a trapezoidal cross-sectional shape.” See id. at 5:64-66, 6:4-5, Fig. 7. See
`
`also Ex. 1002 at ¶ 16.
`
`
`
`Bone fixation body 16 is formed of a porous metal such as, for example,
`
`titanium, and “has a completely porous structure that extends throughout the entire
`
`body from the proximal surface 40 to distal end surface 42.” Ex. 1001 at 3:33-35.
`
`“By ‘porous,’ it is meant that the material at and under the surface is permeated
`
`with interconnected interstitial pores that communicate with the surface.” Id. at
`
`3:51-53. Further, the specification explains that “body 16 does not include a solid
`
`metal substrate.” Id. at 3:35-36. See also Ex. 1002 at ¶ 17.
`
`6
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,506,642
`
`
`
`The specification broadly describes the porous structure as being “adapted
`
`for the ingrowth of cancellous and cortical bone spicules” and having a size and
`
`shape that “emulates the size and shape of the porous structure of natural bone.”
`
`Ex. 1001 at 3:57-61. In certain disclosed embodiments, “the average pore diameter
`
`of body 16 is about 40 µm to about 800 µm with a porosity from about 45% to
`
`65%. Further, the interconnections between pores can have a diameter larger than
`
`50-60 microns.”1 Id. at 3:61-64. The specification explains, however, that
`
`“[a]though specific ranges are given for pore diameters, porosity, and
`
`interconnection diameters, these ranges are exemplary and are applicable to one
`
`exemplary embodiment.” Id. at 4:1-3. See also Ex. 1002 at ¶ 18.
`
`
`
`The ’642 patent discloses that the porous structure can be fabricated using
`
`well-known materials and techniques such as “sintering titanium, titanium alloy
`
`powder, metal beads, metal wire mesh, or other suitable materials, metals, or alloys
`
`known in the art.” Ex. 1001 at 3:54-56. However, the ’642 patent does not
`
`disclose any processes, materials, or material characteristics specifically for
`
`achieving a porous structure that “emulates a size and shape of the porous structure
`
`of natural bone.” The ’642 patent also discloses that the neck body can be formed
`
`
`
`1 The disclosed ranges overlap with known pore diameters and porosities of
`
`cancellous bone. Ex. 1002 at ¶ 18 (citing Ex. 1013).
`
`7
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`
`Petition for Inter Partes Review of U.S. Patent No. 8,506,642
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`using well-known machining techniques. See id. at 4:10-12. In certain disclosed
`
`embodiments, these bodies are fabricated independently and subsequently
`
`connected or fused together. See id. at 4:39-41, 4:44-48. See also Ex. 1002 at ¶
`
`19.
`
`
`
`The ’642 patent includes 4 claims, of which claims 1, 2, and 3 are
`
`independent. See Ex. 1001 at 6:24-8:27. Independent claims 1, 2, and 3 are all
`
`directed to a hip implant including, among other things, “a neck body” and “a bone
`
`fixation body” that is formed as a “completely porous metal structure.” Id. at 6:24-
`
`8:27. The claims recite that the porous structure “emulate[s] a size and a shape of
`
`a porous structure of natural human bone” (claim 1) or “emulates a porous
`
`structure of natural human bone” (claims 2 and 3). Id. See also Ex. 1002 at ¶ 20.
`
`B.
`
`Prosecution History of the ’642 Patent and Its Parent Application
`1.
`Applicant filed the parent application to the ’642 patent, the ’069
`
`Prosecution of the Parent Application
`
`application, with three independent claims broadly reciting a “bone fixation body”
`
`formed of a “completely porous structure.” Ex. 1003 at 177-79. These claims
`
`were rejected as being anticipated by multiple references. Id. at 111-118, 140-147.
`
`Applicant appealed the Examiner’s final rejection of the claims, disagreeing with
`
`the Examiner’s interpretation of the term “porous” and arguing that the applied
`
`reference did not teach a “completely porous structure”. Id. at 57-58.
`
`8
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,506,642
`
`In its decision on appeal, the Board identified the issue on appeal as being
`
`“the proper interpretation of ‘completely porous’.” Id. at 58. The Board found that
`
`while the term “porous” is explicitly defined, the term “completely porous” is not.
`
`Id. at 59. The Board construed the term “completely porous” to mean “entirely
`
`porous,” finding that that this interpretation was consistent with the specification
`
`“which describes the porous structure as extending ‘entirely’ through the implant
`
`body.” Id. (internal citations omitted).
`
`Based on the Board’s interpretation of the term “completely porous,” the
`
`Board affirmed-in-part the Examiner’s rejections of, among other things, the
`
`independent claims, and reversed the rejections of certain dependent claims which
`
`recited various cross-sectional shapes of the bone fixation body. Id. at 67. In
`
`response, Applicant placed these dependent claims in independent form and
`
`cancelled the remaining claims. Id. at 45-49. The Examiner, however, rejected the
`
`amended claims as obvious over the applied prior art stating:
`
`it would have [] been an obvious matter of design choice
`to one skilled in the art at the time of the invention was
`made to construct the bone fixation body of [the prior art]
`with a horizontal cross-section having a . . . trapezoidal
`shape, since applicant has not disclosed that such solve[s]
`any state problem or is anything more than one of
`numerous shapes or configurations a person ordinary
`
`9
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`Petition for Inter Partes Review of U.S. Patent No. 8,506,642
`
`skill in the art would find obvious for the purpose of
`providing a hip implant cross-section.
`Id. at 39 (emphasis in original). Applicant then further amended the claims to
`
`recite that the porous structure “has an average pore diameter of about 40
`
`micrometers to about 800 micrometer [sic], has a porosity from about 45% to 65%,
`
`has interconnections between pores with a diameter larger than 50-60 microns, and
`
`is doped with a biologically active substance to induce bone growth entirely
`
`through the completely porous structure,” (id. at 27-32) but abandoned the
`
`application after the Examiner maintained the rejections (id. at 9-17).
`
`The ’642 Patent Prosecution
`
`2.
`Applicant filed the ’642 patent application, which matured into the ’642
`
`patent, with three broad independent claims such as claim 21, reciting “a bone
`
`fixation body having a porous structure that continuously extends, in a cross-
`
`sectional view of the bone fixation body, through the bone fixation body.” Ex.
`
`1004 at 274-79 (including similarly broad independent claims 28 and 34).
`
`The Examiner rejected the independent claims and their dependent claims
`
`over numerous anticipatory references including U.S. Patent No. 5,552,894
`
`(referred to as Draenert II). Id. at 219-26. In order to distinguish Draenert II,
`
`Applicant amended independent claim 21 to recite, among other things, that the
`
`porous structure of the bone fixation body “has a size and a shape that emulate a
`
`size and a shape of a porous structure of natural human bone.” See id. at 196-207
`
`10
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`Petition for Inter Partes Review of U.S. Patent No. 8,506,642
`
`(including similar changes to claims 28 and 34). Applicant argued that “[t]he
`
`spherical structure taught in Draenert II does not have a size and shape that
`
`emulate a size and a shape of a porous structure of natural human bone” (id. at
`
`204) and submitted a declaration under 37 C.F.R. 1.132 (id. at 194-5) in support of
`
`this statement. In response, the Examiner found the declaration insufficient and
`
`sustained the rejection stating that “[t]he porous structure disclosed in [the prior
`
`art] is intended to behave like or imitate the behavior of bone by providing pores of
`
`a certain size and shape to provide bone ingrowth.” Id. at 182-83. On appeal, the
`
`Examiner maintained his positions and stated the following:
`
`It is [] noted that the porous structure is being claimed in
`a functional language recitation rather than a positive
`recitation setting forth the specific structural features of
`the porous structure. The porous structure disclosed in
`Draenert II is intended to behave like or imitate the
`behavior of bone by providing pores of a certain size and
`shape to provide bone ingrowth. While the structure of
`the instant Applicant [sic] may more closely ‘emulate’ or
`‘replicate’ the size and shape of the porous structure of
`natural human bone, Draenert II attempts to emulate and
`replicate a size and a shape of a porous structure of
`natural human bone.
`
`Id. at 105.
`
`11
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`

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`Petition for Inter Partes Review of U.S. Patent No. 8,506,642
`
`Applicant conceded to this understanding of a porous structure that emulates
`
`the size and shape of a porous structure of natural human bone and subsequently
`
`dismissed the appeal by filing a Request for Continued Examination (RCE). Id. at
`
`53-54. Rather than further addressing the porous structure, Applicant included
`
`amendments detailing that the bone fixation body has “a trapezoidal shape in a
`
`horizontal cross-sectional view.” Id. 55-64; see also id. at 34-46 (Supplemental
`
`Amendment and Response). Following an Applicant-initiated Examiner interview,
`
`the Examiner issued a notice of allowability cancelling all but four claims, and
`
`amending each remaining independent claim (now claims 1-3) to recite, among
`
`other things, that “[an] interface [between a proximal end of a bone fixation body
`
`and a distal end surface of a neck body] has a trapezoidal cross-sectional shape in
`
`which the trapezoidal cross-sectional shape continues and tapers in a distal
`
`direction toward a distal end of the bone fixation body.” Id. at 16-20.
`
`VI. CLAIM CONSTRUCTION
`In an inter partes review, claim terms are given their broadest reasonable
`
`interpretation (BRI).2 In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1275-79
`
`
`
`2 Petitioner notes that district courts apply a different claim construction standard
`
`and reserves its rights to make arguments based on that standard in the district
`
`court. Should the Board’s claim construction standard change during the course of
`
`12
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`

`
`Petition for Inter Partes Review of U.S. Patent No. 8,506,642
`
`(Fed. Cir. 2015). Under this standard, claim terms are given their “broadest
`
`reasonable interpretation, consistent with the specification.” In re Yamamoto, 740
`
`F.2d 1569, 1571 (Fed. Cir. 1984); Office Patent Trial Practice Guide, 77 Fed. Reg.
`
`48,756, 48,764 (Aug. 14, 2012). Claim terms are also “generally given their
`
`ordinary and customary meaning,” which is the meaning that the term would have
`
`to a person of ordinary skill in the art3 at the time of the invention. See In re
`
`Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007) (quoting Phillips v.
`
`AWH Corp., 415 F.3d 1303, 1312, 1313 (Fed. Cir. 2005) (en banc)). Petitioner
`
`proposes a construction for a few of the claim terms below, but all of the claim
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`terms in the ’642 patent should be given their plain and ordinary meaning under
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`the BRI standard.
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`
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`the proceeding, Petitioner reserves its rights to make arguments based on the new
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`standard.
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`3 A person of ordinary skill in the art would have had an undergraduate degree in a
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`relevant engineering field (e.g., Mechanical Engineering, Materials Science
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`Engineering, Biomedical Engineering) with 3-5 years of experience with hip
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`implants or similar implants or a graduate degree in a relevant field with 1-3 years
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`of experience with hip implants or similar implants.
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`Petition for Inter Partes Review of U.S. Patent No. 8,506,642
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`“Completely Porous Metal Structure” (Claims 1-3)
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`A.
`Each independent claim of the ’642 patent includes a “bone fixation body,”
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`and recites that the bone fixation body is formed as a “completely porous metal
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`structure.” Ex. 1001 at 6:29-34, 6:60-67, 7:25-8:3. In the context of the ’642
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`patent, the broadest reasonable interpretation of the phrase “completely porous
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`metal structure” is “a metal structure that is entirely porous.”
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`This interpretation is consistent with the plain and ordinary meaning of the
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`phrase as well as the specification and the Office’s findings during prosecution.
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`For example, the ’642 patent discloses that “[i]n one exemplary embodiment, the
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`bone fixation body portion of the hip implant is completely porous. This porous
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`structure extends entirely through the body of the implant along the region where
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`the implant engages femoral bone.” Id. at 2:8-11; see also id. at 3:31-34 (“In the
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`exemplary embodiments of FIGS. 1 and 2, bone fixation body 16 . . . has a
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`completely porous structure that extends throughout the entire body from the
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`proximal end surface 40 to distal end surface 42.”).
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`During prosecution of the parent application, the ’069 application, the Board
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`found the term “completely porous” to mean “entirely porous,” and explained that
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`this interpretation was consistent with the specification “which describes the
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`porous structure as extending ‘entirely’ through the implant body.” Ex. 1003 at 59.
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`Petition for Inter Partes Review of U.S. Patent No. 8,506,642
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`Thus, the broadest reasonable interpretation of “completely porous metal structure”
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`is “a metal structure that is entirely porous.”
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`B.
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`“[A] Porous Structure . . . That Emulate[s] a Size and a Shape of a
`Porous Structure of Natural Human Bone” (Claim 1) / “[A]
`Porous Structure . . . [That] Emulates a Porous Structure of
`Natural Human Bone” (Claim 2 and 3)4
`The independent claims of the ’642 patent all include a “bone fixation
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`body.” Claim 2 and 3 recite that “[a] porous structure of the bone fixation body
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`emulates a porous structure of natural human bone” (id. at 7:18-19, 8:22-23), and
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`claim 1 recites that “[a] porous structure of the bone fixation body has a size and
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`shape that emulate a size and a shape of a porous structure of natural human bone”
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`(id. at 5:52-54) (referred to hereinafter as “the “emulating” claim features”). To
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`the extent that these phrases are amenable to construction, the broadest reasonable
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`interpretation includes “a structure that is sufficiently porous so as to permit bone
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`ingrowth.” This interpretation is consistent with the plain language of the claims,
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`the specification, and the prosecution history of the ’642 patent application.
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`The plain and ordinary meaning of the term “emulate” is “imitate.” Ex.
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`1008 at 3. Thus, the plain language of the claims simply requires the porous
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`4 These phrases raise issues under 35 U.S.C. § 112 (e.g., enablement and
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`indefiniteness). Petitioner understands that such grounds cannot be raised in this
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`proceeding, but reserves the right to argue them where appropriate.
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`15
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`Petition for Inter Partes Review of U.S. Patent No. 8,506,642
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`structure of the bone fixation body to “imitate” the porous structure of natural
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`human bone. This understanding is not inconsistent with the specification, which
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`equates “[t]he porous structure of body 16 [] adapted for the ingrowth of
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`cancellous and cortical bone spicules” with “emulate[ing] the size and shape of the
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`porous structure of natural bone.” Ex. 1001 at 3:57-61. To adapt a porous
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`structure for ingrowth and emulate natural bone, the specification discloses
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`exemplary or preferred
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`ranges
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`for
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`the pore diameter, porosity, and
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`interconnections. For example, the specification provides that “the average pore
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`diameter of body 16 is about 40µm to about 800µm with a porosity from about
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`45% to 65%. Further, the interconnections between pores can have a diameter
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`larger than 50-60 microns.” Id. at 3:61-64. The specification provides that “[i]n
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`short, the geometric configuration of the porous structure should encourage natural
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`bone to migrate and grow into and throughout the entire body 16.” Id. at 3:64-67.
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`The proposed construction is also consistent with the Office’s interpretation
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`of the claim language during prosecution of the ’642 patent application. During
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`prosecution, Applicant attempted to overcome the applied prior art by amending
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`the claims to include the “emulating” claim features. In response, the Examiner
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`rejected an interpretation of the claims that would require the porous structure to
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`resemble or “replicate” the porous structure of natural bone. Ex. 1004 at 182-3.
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`Instead, the Examiner maintained the prior art rejections explaining that “[t]he
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`16
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`Petition for Inter Partes Review of U.S. Patent No. 8,506,642
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`porous structure disclosed in [the prior art] is intended to behave like or imitate the
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`behavior of bone by providing pores of a certain size and shape to provide bone
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`ingrowth.” Id. at 183; see also id. at 105. Applicant acquiesced to this
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`interpretation, ultimately abandoning this argument as the patentable distinction
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`between the claims and the prior art, and instead focusing on a “trapezoidal shape”
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`of an interface between the bone fixation body and neck body. Id. at 16-20.
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`Thus, the broadest reasonable interpretation of the phrases “[a] porous
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`structure . . . [that] emulates a porous structure of natural human bone” (claims 2
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`and 3) / “[a] porous structure . . . that emulate[s] a size and a shape of a porous
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`structure of natural human bone” (claim 1) includes “a structure that is sufficiently
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`porous so as to permit bone ingrowth.” To the extent Patent Owner argues that the
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`phrases should be more narrowly construed, such a construction is not supported
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`by the ’642 patent.
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`VII. CLAIMS 1-4 OF THE ’642 PATENT ARE UNPATENTABLE
`A. The Board Should Adopt Both of the Proposed Grounds
`Zolman and Rostoker render claims 1-4 obvious under Petitioner’s
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`construction of the “emulating” claim features. See infra Section VII.B (Ground
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`1). Zolman and Bobyn render claims 1-4 obvious under a narrower claim
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`interpretation where the “emulating” claim features require the porous structure of
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`the claimed “bone fixation body” to resemble a porous structure of natural human
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`17
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`Petition for Inter Partes Review of U.S. Patent No. 8,506,642
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`bone. See infra Section VII.C (Ground 2). The Board should adopt both grounds
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`in the event Patent Owner argues for a narrower construction either in its
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`Preliminary Response or after in